FDA warns medical device manufacturer over 'MRI-safe' claims
The U.S. Food and Drug Administration has issued a warning to a manufacturer of ventilators over shortcomings relating to their alleged MRI compatibility.
Massachusetts-based Zoll Medical Corp. makes several medical devices, including defibrillators, monitors and ventilators. Some of the company’s ventilators have been designed specifically for use in MRI settings, but a recent FDA inspection is raising questions about these claims.
Zoll recently received a warning from the agency regarding numerous quality safety issues. One of the shortcomings highlighted in the letter pertains to the labeling of its 731 Series MRI-compatible ventilators. The device packaging indicates that they are compatible with both 1.5 and 3T MRI scanners. However, Zoll’s records indicate that the devices were only tested on 3T scanners. What’s more, the label is missing vital safety information.
“No rationale or justification for lack of testing with the 1.5T MRI scanner was documented. Based on the testing, it was determined that the ventilator should be placed behind the 130 Gauss field line (approximately to the bore opening of a 3T MRI magnet); however, the labeling fails to specify how far the ventilator should be placed when using 1.5T MRI,” the letter reads.
Records from 2024 also revealed that the company received a complaint about use of the ventilator near a 1.5T scanner. That complaint indicates that the image quality suffered as a result of the ventilator being near the bore of the magnet.
Although Zoll responded to the FDA’s initial findings, the agency deemed its answers inadequate. The company now has 15 days to respond with additional information.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.